The
journal, Statistics in Medicine, has just published an important article that
compares the number of single-sex studies done for men and women, and compares
that number with the disease burden faced by both sexes. The study,
"Estimation of Gender Bias in Clinical Trials" looks at articles
published from 1966-1995.

The
article, written by Johns Hopkins researchers Curtis Meinert and Adele Gilpin,
concludes that while women were underrepresented in heart disease trials, men
were underrepresented both in cancer and in other trials.

The article
further abolishes the myth that women were "routinely excluded" from
medical research.

The article
is published in the current issue of Statistics in Medicine.

The
perception is that the clinical trials enterprise has been biased in favour of
males by devoting a disproportionate effort to males and to the diseases and
conditions afflicting them - a perception reinforced by a few high profile
male-only heart trials undertaken in the 1970s and 1980s. The perception was
sufficient to cause the U.S.A. Congress to enact legislation to require that a
clinical trial is designed and carried out in a manner sufficient to provide for
a valid analysis of whether the variables being studied in the trial
affect women differently than other subjects in the trial. Observed effort
differentials are based on counts of single-gender trials indexed in MEDLINE and
published in U.S. journals. Differentials are compared to those expected using
male-female differentials in mortality and years of potential life loss due to
mortality before age 65 to estimate effort bias. The ratios of female-only to
male-only published trials were 0.53, 0.89 and 0.95 for the decades of
1966-1975, 1976-1985 and 1986-1995, respectively. The expected ratios, if
single-gender trials were done in proportion to female-male mortality
differentials, would be 0.57, 0.56 and 0.57, respectively. The differences in
observed versus expected female to male ratios correspond to a slight excess of
male-only trials in the decade of 1966-1975 and to sizeable excesses in
female-only trials in the decades of 1976-1985 and 1986-1995. The results
do not support the perception that women have been understudied relative to
males in clinical trials. Most differentials favour females, whether based
on mortality or years of potential life loss due to mortality before age 65
years. Copyright 2001 John Wiley & Sons, Ltd.